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AAMC Submits Joint Letter on NPRM to Further Delay Revised Common Rule

May 18, 2018

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PRESS CONTACTS
Heather Pierce, Sr. Director, Science Policy & Regulatory Counsel
Daria Grayer, SA- Lead Specialist, Science Policy and Regulation

The AAMC May 16 submitted a letter co-signed by the Association of American Universities (AAU), Association of Public and Land-grant Universities (APLU), and Council on Governmental Relations (COGR), to the Department of Health and Human Services (HHS) in response to a request for comments on the April 20, 2018 Notice of Proposed Rulemaking (NPRM) to delay the general compliance date for the revised Common Rule to January 21, 2019 [see Washington Highlights, April 20, 2018]. This NPRM follows the January 22, 2018 publication of an Interim Final Rule delaying the regulation’s effective and compliance dates until July 19, 2018 [see Washington Highlights, January 19, 2018].  HHS seeks comment by May 21, 2018, on the new proposed compliance date and whether to allow institutions to implement three “burden reducing” provisions identified in the revised rule prior to the 2019 general compliance date. The NPRM requests comment only on the timing of the implementation of the revised Common Rule, not the substance of the rule’s requirements.

The four associations supported the proposal to delay the general compliance date of the revised regulations until January 21, 2019, and also the proposal to allow the voluntary adoption of three “burden reducing” provisions in the 2018 requirements during the six-month delay period. The associations urged prompt issuance of agency guidance to help ensure consistent interpretation and implementation across institutions, underscoring concerns raised in a June 2017 joint letter to the Office for Human Research Protections that the regulated community would not be able to implement the revised regulations by the initial scheduled compliance date in the absence of key guidance [see Washington Highlights, June 23, 2017].

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